Registration Dossier
Registration Dossier
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EC number: 297-462-0 | CAS number: 93572-32-8
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
The chemical safety assessment according to Annex I of Regulation (EC) No. 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish.
Key value for chemical safety assessment
Additional information
No data evaluating the chronic toxicity of Glycerides, palm-oil mono-, hydrogenated, acetates (CAS No. 93572-32-8) to fish species are available. The environmental exposure assessment performed for this substance (see Chapters 9 and 10 of the CSR for detailed information) shows that the Risk Characterization Ratios (i.e. PEC/PNEC ratio) in the aquatic compartment (freshwater and marine) are < 1 and therefore, under the current exposure conditions, Glycerides, palm-oil mono-, hydrogenated, acetates does not pose a risk to aquatic organisms and further testing is not deemed necessary according to Regulation (EC) No. 1907/2006, Annex XI, section 3.
Glycerides, palm-oil mono-, hydrogenated, acetates is readily biodegradable (86.7% in 28 days) and therefore, according to the Guidance on information requirements and chemical safety assessment, Chapter R.7b (ECHA, 2008), this substance will undergo rapid and ultimate degradation in most environments, including biological Sewage Treatment Plants (STPs). Based on this information, concentrations of the substance into the aquatic compartment from STP releases and therefore, the bioavailability to aquatic organisms, are expected to be low. Furthermore, the substance exhibits a log Koc value > 3. Therefore, once the substance enters conventional STPs, it is expected to be removed from the water column to a significant degree by adsorption to sewage sludge (Guidance on information requirements and chemical safety assessment, Chapter R.7a, (ECHA, 2008)) and the rest will be extensively biodegraded (due to ready biodegradability). Based on the results of the acute tests performed with species representing three different trophic levels (fish, aquatic invertebrates and algae), fish was the species showing the least sensitivity (no toxicological effects observed up to the limit of water solubility). According to the Guidance on information requirements, Chapter R.7b (ECHA, 2008) if it can be proven through experimental data that fish is at least a factor of 10 less sensitive than aquatic invertebrates and algae, no further testing requirements are necessary for this endpoint. The acute tests conducted on fish species showed no toxicological effects whereas the EC50 and NOEC values for aquatic invertebrates and algae are 64.4 and 0.565 mg/L (respectively).
Based on the above information and due to concerns of animal welfare, long-term testing on fish is not proposed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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